FDA.reportPublic FDA data

NDC 58177-092 - Benzonatate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58177-092
Package NDCs from labels
58177-092-04
Manufacturer
ETHEX Corporation
Effective date
2008-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benzonatate - ETHEX CorporationETHEX Corporation2008-12-30HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-092-04Benzonatate100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-092BENZONATATE CAPSULE [ETHEX CORPORATION]11 package rows20090108_51a6d28c-2c9c-4e6b-8a4c-29aac6745256.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [ETHEX CORPORATION]1
BenzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [ETHEX CORPORATION]1
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [ETHEX CORPORATION]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [ETHEX CORPORATION]1
methyl/propyl paraben blendINACTIVE INGREDIENTBENZONATATE CAPSULE [ETHEX CORPORATION]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [ETHEX CORPORATION]1
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [ETHEX CORPORATION]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEMajor Pharmaceuticals324f65ae-09d1-4bd6-9d2b-593035201ecd2026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEREMEDYREPACK INC.9815f3f4-fb46-4796-a0ed-62a9e098286d2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepack0151d970-fd80-482d-ad92-03015eef26182026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATERedpharm Drug5833ad0e-daae-1a93-e063-6394a90af88e2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEEpic Pharma LLC9b35e9d5-7d72-4f51-a245-ad2467ab40e92026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATESportpharm LLCdf48d617-a3c2-4776-937d-ccfca651d4fc2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy3f686042-02bc-8a78-e063-6294a90a7f562026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEBryant Ranch Prepack5728b147-33a0-4534-b936-3e02274d94672026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEMajor Pharmaceuticals2256f7e4-b7e6-433f-941e-bf78ddcd55b22026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEGolden State Medical Supply, Inc.d580b1c9-d450-4032-acb2-0563c589ed2c2026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEA-S Medication Solutionse6f5f2c2-1c59-405c-97bf-ee73740869d22026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEA-S Medication Solutions434130e1-c29c-4029-92c6-7d0f7a928e682026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197397
BenzonatateBENZONATATEBryant Ranch Prepackda093b5e-83a7-467e-9716-bc5827a18c202026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepack865a6317-c697-4dbe-9074-4a955036cdd72026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepack0f91fd98-1a86-42aa-8055-d339bff730152026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 283417
BenzonatateBENZONATATEBionpharma Inc.2630be01-1d2d-4c40-8e56-8568ea89eacf2026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BENZONATATEBENZONATATEStrides Pharma Science Limited89f5d18e-5ef4-42a3-bc6f-abf4f308462b2026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy96250e05-4608-7d5c-e053-2995a90ad57a2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 197397
benzonatateBENZONATATEBryant Ranch Prepacka788cb01-6dc3-4f28-aaa0-c23ac058c39a2026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197397
rxcui: 283417
BenzonatateBENZONATATEBryant Ranch Prepack540d2bc6-11dc-43d7-b616-b89d75b81cd12026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 197397

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.